The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

Launched by TINA VILSBØLL · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called tirzepatide on people who are overweight or obese and have stable coronary artery disease (CAD). The researchers want to see if tirzepatide, which is taken once a week, can change the makeup of plaque in the arteries, reduce the amount of plaque, and improve blood flow in the heart over a period of 52 weeks. The trial also includes a smaller study to find out what factors might predict the buildup of plaque in these patients.

To participate in this trial, individuals must be 18 years or older, have a body mass index (BMI) of 27 or higher, and have been referred for a coronary angiogram due to stable angina (chest pain). However, certain conditions may exclude a person from joining, such as having diabetes or previous heart surgeries. If eligible, participants will receive either tirzepatide or a placebo (a harmless pill with no active medication) to compare the effects. This trial is currently recruiting participants, and it provides an opportunity for individuals to contribute to important research about heart health and obesity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed written consent
• • BMI equal to or above 27 kg/m2
• • Age 18 years or older
• • Referred to coronary angiogram (CAG) due to stable angina
• • Coronary atheromatosis by angiography (obstructive or non-obstructive)
• • LCBI4mm \>200 by NIRS in a vessel not subjected to coronary intervention
• Exclusion Criteria:
• • History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at baseline
• • Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)
• • History of coronary artery bypass surgery (CABG)
• • Planned CV intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of randomisation
• • History of heart failure New York Heart Association (NYHA) class III or IV
• • Left ventricular ejection fraction (LVEF) ≤35%
• • eGFR \<30 ml/min/1.53 m2
• • History of pancreatitis or plasma amylase \>2 times upper normal limit
• • Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal)
• • Pregnancy, planned pregnancy or breastfeeding
• • Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)
• • Hypersensitivity to the active substance (Tirzepatide) or to any of the excipients
• • Left main stenosis (≥50% diameter or haemodynamically significant)
• • Chronic total occlusion of any major coronary vessel
• • Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery
• • Coronary anatomy or pathology precluding the safe performance of intravascular imaging in all major coronary arteries not subjected to intervention